Validation of acute myocardial infarction in the Food and Drug Administration's Mini‐Sentinel program

Abstract

Purpose To validate an algorithm based upon International Classification of Diseases, 9th revision, Clinical Modification (ICD-9-CM) codes for acute myocardial infarction (AMI) documented within the Mini-Sentinel Distributed Database (MSDD). Methods Using an ICD-9-CM-based algorithm (hospitalized patients with 410.x0 or 410.x1 in primary position), we identified a random sample of potential cases of AMI in 2009 from 4 Data Partners participating in the Mini-Sentinel Program. Cardiologist reviewers used information abstracted from hospital records to assess the likelihood of an AMI diagnosis based on criteria from the joint European Society of Cardiology and American College of Cardiology Global Task Force. Positive predictive values (PPVs) of the ICD-9-based algorithm were calculated. Results Of the 153 potential cases of AMI identified, hospital records for 143 (93%) were retrieved and abstracted. Overall, the PPV was 86.0% (95% confidence interval; 79.2%, 91.2%). PPVs ranged from 76.3% to 94.3% across the 4 Data Partners. Conclusions The overall PPV of potential AMI cases, as identified using an ICD-9-CM-based algorithm, may be acceptable for safety surveillance; however, PPVs do vary across Data Partners. This validation effort provides a contemporary estimate of the reliability of this algorithm for use in future surveillance efforts conducted using the FDA’s MSDD.

Choice of ICD‐10 codes for the identification of acute coronary syndrome in the French hospitalization database

“…Interestingly, taken alone, the I20.0 code for unstable angina was relatively predictive of ACS but not very predictive of unstable angina, while the I21 code for acute MI was highly predictive of both ACS and STEMI/NSTEMI. Considering the code combinations, I21 with I24 had the highest PPV for ACS, yet the combination I20.0, I21 or I24 identified a notably greater number of validated cases while maintaining an acceptable PPV, similar to that of the validated ICD-9 codes for ACS identification [8,9]. Furthermore, although the PPV of I20.0 for unstable angina was much higher than that of I21, both identified a similar number of validated events.…”

“…Pharmacology has been performed for MI or ACS identification in North American databases that use ICD-9 (International Classification of Diseases and Related Health Problems, 9 th Edition) [8,9] as well as for MI in many European databases that use the more recent 10 th Edition (ICD-10) [10,11]. However, MI or ACS coding has not been evaluated in the French hospitalization database (Programme de M edicalisation des Syst emes d'Information, PMSI) that is the national database used by all hospitals in France.…”

Comparative effects of biologics on cardiovascular risk among older patients with rheumatoid arthritis

“…We directly assessed the clinical outcomes and not surrogate outcomes. We used validated algorithms to exclude patients with prevalent coronary heart disease (CHD) and to identify incident CHD outcomes 16 23. We included a set of carefully chosen CVD risk factors, in addition to demographics and use of health services, in the adjusted analysis.…”

Chart validation of inpatient ICD‐9‐CM administrative diagnosis codes for acute myocardial infarction (AMI) among intravenous immune globulin (IGIV) users in the Sentinel Distributed Database

“…Since not all AMI cases are identified with algorithms based on the principal diagnosis field only, a common study design dilemma is whether to also use other types of AMI administrative diagnoses (eg, secondary inpatient diagnoses and emergency department diagnoses) to identify AMIs. While the high PPV of principal inpatient diagnoses for AMI was confirmed by a prior validation study conducted within the SDD, to date, the validity of nonprincipal inpatient AMI diagnoses has not been assessed in the SDD. To provide researchers and other stakeholders with data on the validity of nonprincipal AMI diagnoses within the SDD, we report on the results of a chart validation study of potential AMI cases identified as part of a safety assessment of intravenous immune globulin (IGIV) products.…”